Conformity assessment with standards


Conformity assessment with standards:

There are four common industrial methods for assessing conformity to a standard.

1. A product’s conformity to standards is commonly assessed by direct testing.

2. A process can be assessed by audit. Certification organizations or regulatory authorities attest that products or processes conform to a standard by authorizing the display of their certification mark.

3. The conformity to management standard by an organization is known as management systems registration, a relatively new term used primarily in North America. Formally established audit procedures are followed by certified auditors who are supported by technical experts of the domain under audit. Management System Registration bodies (Registrars) issue registration certificates to companies that meet a management standard such as ISO 9000, or to medical device manufacturers that meet the ISO 13485 / ISO 9001 standards.

Note that in North America, the term “registration” is used for an organization while “certification” is reserved for products. Many other countries use “certification” for both a product and an organization.

4. Accreditation is used by an authoritative body to give formal recognition that an organization or a person is competent to carry out a specific task. For example, in Europe, Notified Bodies are notified or accredited by the relevant State Competent Authority to carry out conformity assessment of medical devices. In Canada, a Quality System Registrar needs an accreditation from Health Canada before that Registrar begins assessing medical device manufacturers for conformity with quality system standards. The International Laboratory Accreditation Cooperation (ILAC) uses accreditation to provide formal recognition to competent laboratories around the world. 

Conformity assessment with standards:

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